The Cambridge biotech’s pipeline consists of ‘mini protein’ conjugate molecules linked to Actinium-225, an alpha-emitting isotope, focusing on breast, lung, bladder, liver, and colorectal cancer therapies. It negotiated supply agreements with NorthStar Medical, Niowave, and TerraPower earlier this month to provide radioisotopes for its programs. Along with Merck’s MRL Ventures Fund, Cowen Healthcare Investments, ArrowMark Partners, Mirae Asset Venture Investment, Timefolio Capital, and Pappas Capital participated in the Series A extension.
Koye Pharma Partners with Sonde Health to Develop its Vocal Biomarker Technology for COPD
Koye Pharma, an Indian pharmaceutical company, has partnered with Sonde Health to develop its vocal biomarker technology, which aims to diagnose diseases based on voice patterns, for use in chronic obstructive pulmonary disease (COPD). Koye, based in Mumbai, is the first pharmaceutical company to collaborate with Sonde Health on the technology, which is also used in a standalone app to monitor people’s mental health and well-being.
The Indian company had already been developing its own vocal biomarker for respiratory diseases but will now combine it with Sonde Health’s technology to develop a new biomarker specifically for India’s 50 million COPD patients. Boston, Massachusetts Sonde Health, a PureTech Health company, has previously tested the technology as a diagnostic for respiratory diseases.
Prior research has shown that a six-second voice sample can detect asthma and COPD symptoms and provide an early warning for COVID-19 infections. Earlier this year, it collaborated with hearing aid specialist GN Group to develop vocal biomarker technology to detect mild cognitive impairment, which can be an early warning sign for diseases such as Alzheimer’s.
Koye sells generic medicines, including COPD therapies such as Spirodin (doxofylline) and Spirodin-Ax (doxofylline and ambroxol), which are used to open the airways and reduce coughing in patients with the respiratory condition.
Novartis Announces Intention to Separate Sandoz to Create a Standalone Company
Novartis announced its plans to separate Sandoz, its generics & biosimilars division, into a new publicly traded standalone company, by way of a 100 per cent spin-off.
The spin-off aims to expand shareholder value by creating the #1 European generics company and a global leader in the filed of biosimilars which allows Novartis shareholders to engage fully in the potential future upside for both, Novartis and Sandoz Innovative Medicines.
For the Innovative Medicines and Sandoz businesses, the spin-off would be able enhance focus and the ability to pursue independent growth strategies. Sandoz is predicted to deliver its next wave of growth based on the existing biosimilar pipeline of 15+ molecules, a solid & experienced team, and organization. Novartis aspires to become a focused innovative medicines firm with a more robust financial profile & improved capital return.
The standalone Sandoz would be headquartered in Switzerland and will be listed on the SIX Swiss Exchange, with an American Depositary Receipt program in the United States.
Our strategic review inspected all the options for Sandoz and concluded that a 100 per cent spin-off is the best option for shareholders. A spin-off would allow our shareholders to profit from the potential future accomplishments of a more focused Novartis and a standalone Sandoz, and would provide differentiated and clear investment theses for individual businesses. Sandoz will become the publicly traded #1 European generics company and a global leader in biosimilars based in Switzerland,” added Joerg Reinhardt, Chair of the Board of Directors, Novartis.
Alcon to Buy Aerie Pharma for About USD 753 Million
The companies, Alcon and Aerie Pharmaceuticals have entered into a definitive merger agreement through which Alcon will acquire Aerie. This transaction confirms Alcon’s commitment to the ophthalmic pharmaceutical space and is predicted to add broader pharmaceutical research and development capabilities to Alcon’s existing commercial expertise, increasing the value of its diversified portfolio.
Through this transaction, Alcon will add the commercial products Rocklatan 0.02 per cent/0.005 per cent and Rhopressa 0.02 per cent, as well as AR-15512, a Phase III product candidate for dry eye disease, and a pipeline assessment of various clinical and pre-clinical ophthalmic pharma product candidates. The transaction accompanies Alcon’s recent expansion into the ophthalmic pharmaceutical eye drop space, including acquisitions of the exclusive United States commercialization rights to Simbrinza from Novartis in April’21 and of Eysuvis and Inveltys from Kala Pharmaceuticals in May’22.
Rocklatan is a fixed-dose combination of the netarsudil, Rho kinase inhibitor, and latanoprost (a prostaglandin F2α analogue), indicated for the reduction of elevated intraocular pressure in patients suffering with open-angle glaucoma or ocular hypertension. Rhopressa is a Rho kinase inhibitor for removing elevated intraocular pressure in patients suffering with open-angle glaucoma or ocular hypertension. In most markets outside the United States, commercialization rights for both products have been licensed to Santen SA and its affiliates.
The purchase price of $15.25 per share serves a premium of 37 per cent to Aerie’s last closing price and an equity value of approximately $770 million. The board approved the transaction of directors of each firm.
Aerie’s most recent financial guidance for total glaucoma franchise net product revenue is $130-140 million for 2022. The transaction is expected to accrue to Alcon’s core diluted Earnings Per Share in 2024. The transaction is expected to close in the fourth quarter of 2022.
FDA Approves Ibrutinib for Pediatric Patients With Chronic GVHD
The Janssen Pharmaceutical has announced that the USFDA has approved its chronic graft-versus-host disease (cGVHD) therapy, IMBRUVICA® (ibrutinib), for the treatment in pediatric patients one year and older with after the failure of one or more lines of systemic therapy. With this approval, IMBRUVICA® became the first FDA-approved therapy for younger patients who previously had no approved treatment options in the cGVHD therapeutics market.
IMBRUVICA® (ibrutinib) approval is based on the results from the Phase 1/2 iMAGINE study, an open-label, multicenter, single-arm trial evaluating the potential of IMBRUVICA® for the treatment of pediatric and young adult patients aged one year to less than 22 years with moderate or severe cGVHD. Owing to its unique kinase profile (e.g., inhibiting both BTK and interleukin-2-inducible T-cell kinase [ITK]), IMBRUVICA® has the potential to provide a better clinical benefit for cGVHD.
In 2013, The U.S. Food and Drug Administration (FDA) first approved IMBRUVICA® and as of today, it is in use for six diseases in adult patients, including five hematologic cancers. Earlier in 2017, IMBRUVICA® was approved to treat adults with cGVHD after failure of one or more lines of systemic therapy. The therapy is approved in over 100+ countries, and nearly 250,000 patients worldwide have been benefitted from it.
FDA Grants Fast Track Designation to Merck’s MK-2060 for ESRD
Merck has announced that the U.S. FDA has granted Fast Track designation to its investigational anticoagulant therapy MK-2060 to reduce the risk of major thrombotic cardiovascular events in patients with End-Stage Renal Disease (ESRD). MK-2060 is an investigational monoclonal antibody currently being studied in the phase II stage in End-Stage Renal Disease (ESRD) patients receiving hemodialysis.
MK-2060 is administered intravenously, and it works through a dual mechanism of action (MoA), blocking the activation of Factor XI and downstream activity of the activated protein. As per the estimates, the current Phase 2 clinical trial of MK-2060 is expected to be completed by April 2023. With the further approval and launch of the therapy MK-2060, Merck’s presence in the cardiovascular therapeutics segment is expected to strengthen.
End-Stage Renal Disease (ESRD), also known as end-stage renal failure, is the final, permanent stage of chronic kidney disease in which kidney function has declined to the point that the kidneys no longer function on their own. In this condition, kidneys only function at 10–15% of their normal capacity, and the patient must receive dialysis or kidney transplantation to survive more than a few weeks. As per DelveInsight, in the United States, the overall prevalence of Chronic Kidney Disease (CKD) is around 14% of the general population.
The therapy, MK-2060, is a novel inhibitor of Factor XI and has the ability to activate downstream proteins involved in the blood coagulation cascade and tends to prevent thrombosis in patients with End-Stage Renal Disease (ESRD). The FDA’s Fast Track Designation to MK-2060 will facilitate the Accelerated Approval and Priority Review if the findings from the clinical studies prove fruitful. The approval of the therapy is expected to play a key role in preventing thrombosis in patients with advanced forms of kidney disease.
France Regulator Gives The Green Light to Bayer’s Asklepios BioPharma to Start Dosing Patients with its Gene Therapy Candidate
Bayer’s Asklepios BioPharma’s (AskBio) BrainVectis has been approved by the France regulatory for the usage of their novel gene therapy candidate to treat Huntington’s disease, a neurogenerative disorder caused by a single defective gene on chromosome 4.
The gene therapy candidate has been given a green light to start Phase I and Phase II clinical trials in which a single shot of BV-101 gene therapy will be administered using the vector adeno-associated virus (AAV) directly to the affected parts of the brain.
The therapy delivers CYP46A1, an enzyme that is reduced in the brains of people with the disorder that is involved in cholesterol metabolism and seems to play a crucial role in the pathogenesis and progression of neurodegenerative disorders.
During the initial phases of animal studies, it was observed that the therapy has shown to persist a neuroprotective effect along with which it aided in repairing a faulty cholesterol pathway and restoring physical function.
As per the founder BrainVectis and vice president of neurobiology at AskBio Nathalie Cartier-Lacave, “the BV-101 aims towards restoring cholesterol metabolism, reducing the mutated Huntingtin genes, and improving neuronal functioning”. The candidate has shown no direct effect on levels of the Huntingtin gene.
Bayer cracked a USD 4 billion deal by acquiring US-based Biotech Asklepios BioPharmaceutical back in 2020 expressing his interest in gene therapy and biotechnology.
Takeda Secures its First Regulatory Approval in Indonesia for its Dengue Fever Vaccine TAK-003
Takeda’s dengue vaccine, QDENGA® was recently approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM). The vaccine focuses on prophylaxis of dengue caused by a number of serotypes in individuals aged between six to 45 years. It is to be noted that the usage of the vaccine is in accordance with the official recommendations. QDENGA stands to be one of the three vaccine candidates officially approved for use within the population.
In the past few years, Indonesia has suffered half of the disease burden inside Southeast Asia i.e. the highest dengue burden in the world. During the initial half of 2020, the country reported around 63K cases of dengue and accounted for around 600 deaths.
QDENGA successfully showed prophylaxis against dengue for more than three years regardless of the patient’s previous dengue records. Moreover, it did not show any serious risks that were previously seen in TIDES trials. The vaccine is genetically modified using a live-attenuated dengue serotype virus-2 which serves to be the genetic backbone of all four dengue subtypes. The vaccine is administered SC 0.5 mL dose at a two-dose on an interval of 3 months. More than 28K participants were tested during the clinical trials of the candidate which included the participants of the TIDES trial.
